Medication info
Olpenazine 10 mg (Solifenacin Succinate)

Olpenazine 10 mg (Solifenacin Succinate)

Prescription medicationTabletOral
Ingredient · strength
Solifenacin Succinate›10mg / 1 tablet
Manufacturer / importer
Dasan Pharmaceuticals Co., Ltd.
Appearance
Bright pink round film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201500293 · Approved 2015.01.20 · Insurance code 665506660,678602200

Summary

Main use
Treatment of symptoms of overactive bladder (e.g., urge urinary incontinence and urinary frequency)
Who takes it
Adults
Adult dose
For adults (including the elderly), the usual recommended dose is 5mg once daily. If necessary, the dose may be increased to a maximum of 10mg once daily. This medication may be taken regardless of meals and should be swallowed whole with water. Dosage adjustment is required for the following patients. 1. Patients with renal impairment: No dosage adjustment is necessary for patients with mild to moderate renal impairment (creatinine clearance>30ml/min). Use with caution in patients with severe renal impairment (creatinine clearance≤30ml/min), and do not exceed 5mg once daily. 2. Patients with hepatic impairment: No dosage adjustment is necessary for patients with mild hepatic impairment. Use with caution in patients with moderate hepatic impairment (Child-Pugh class B), and do not exceed 5mg once daily. 3. Patients receiving potent cytochrome P450 3A4 (CYP3A4) inhibitors: Limit the maximum daily dose to 5mg in patients receiving ketoconazole or other potent CYP3A4 inhibitors (e.g., ritonavir, nelfinavir, itraconazole).

Ingredients

Manufacturer
Dasan Pharmaceuticals Co., Ltd.

Efficacy & effects

Treatment of symptoms of overactive bladder (e.g., urge urinary incontinence and urinary frequency)

  • Urgency urinary incontinence
  • frequent urination
  • urinary urgency
View approved original text

This medication helps relieve symptoms such as urgency urinary incontinence, frequent urination, and urinary urgency caused by overactive bladder. It controls abnormal contractions of the bladder to reduce the frequency of urges to urinate and the urgent desire to urinate. It assists in significantly alleviating discomfort experienced in daily life and contributes to symptom relief and improved quality of life. This medication is used to effectively treat symptoms of overactive bladder.

How to take

Adult dose

For adults (including the elderly), the usual recommended dose is 5mg once daily. If necessary, the dose may be increased to a maximum of 10mg once daily. This medication may be taken regardless of meals and should be swallowed whole with water. Dosage adjustment is required for the following patients. 1. Patients with renal impairment: No dosage adjustment is necessary for patients with mild to moderate renal impairment (creatinine clearance>30ml/min). Use with caution in patients with severe renal impairment (creatinine clearance≤30ml/min), and do not exceed 5mg once daily. 2. Patients with hepatic impairment: No dosage adjustment is necessary for patients with mild hepatic impairment. Use with caution in patients with moderate hepatic impairment (Child-Pugh class B), and do not exceed 5mg once daily. 3. Patients receiving potent cytochrome P450 3A4 (CYP3A4) inhibitors: Limit the maximum daily dose to 5mg in patients receiving ketoconazole or other potent CYP3A4 inhibitors (e.g., ritonavir, nelfinavir, itraconazole).

Precautions

This medication should not be administered to patients with certain conditions. For example, it should not be used in patients with urinary retention, serious gastrointestinal issues, severe myasthenia gravis, narrow-angle glaucoma, allergies to this medication or its components, patients undergoing hemodialysis, or patients with severe liver or kidney impairment. Additionally, it should be administered with caution in certain patients. For example, patients at risk of urinary obstruction, gastrointestinal obstruction diseases, or with a risk of decreased gastrointestinal motility, severe kidney impairment, or moderate liver impairment, as well as patients taking strong CYP3A4 inhibitors should be closely monitored. Using this medication may lead to dry mouth, constipation, blurred vision, or difficulty urinating. These side effects tend to occur more frequently at higher doses. In severe cases, significant gastrointestinal issues such as bowel obstruction may occur, so patients should consult a doctor immediately if symptoms worsen. This medication can cause cardiac rhythm abnormalities; thus, patients with heart disease or high potassium levels should take special care. Rarely, serious allergic reactions such as angioedema or anaphylaxis may occur, and immediate treatment is necessary if such symptoms present. Caution is also required when driving or operating machinery due to side effects like drowsiness or blurred vision. Co-administration with other anticholinergic medications may enhance effects or lead to undesired side effects, so consultation with a doctor is advised. Safety during pregnancy has not been established, therefore caution is necessary during use, and breastfeeding women should avoid using this medication as it can be transferred into breastmilk. The safety in children has also not been confirmed, so it should not be administered to them. In case of overdose, symptoms such as headache, dizziness, drowsiness, and blurred vision may occur, and immediate hospital treatment should be sought. Gastric lavage or administration of activated charcoal may be necessary in overdose cases. Before taking this medication, patients must consult medical staff regarding potential drug interactions, particularly if co-administered with strong CYP3A4 inhibitors, where dosage adjustments may be required.

Side effects

  • Dry mouth
  • constipation
  • blurred vision
  • urinary retention
  • dry eyes
  • fecal impaction
  • colonic obstruction
  • intestinal obstruction
  • angioedema
  • nausea
Show 64 more
  • dyspepsia
  • abdominal pain
  • vomiting
  • urinary tract infection
  • influenza
  • pharyngitis
  • dizziness
  • depression
  • peripheral edema
  • fatigue
  • cough
  • hypertension
  • difficulty in urination
  • reduced urine flow
  • post-void residual
  • cystitis
  • nasopharyngitis
  • vomiting
  • gastroesophageal reflux disease
  • intestinal obstruction
  • peripheral edema
  • headache
  • hallucinations
  • drowsiness
  • delirium
  • kidney impairment
  • itching
  • rash
  • urticaria
  • angioedema
  • erythema multiforme
  • exfoliative dermatitis
  • atrial fibrillation
  • palpitations
  • tachycardia
  • polymorphic ventricular tachycardia
  • QT prolongation on ECG
  • abnormal liver function tests
  • decreased appetite
  • hyperkalemia
  • speech disturbance
  • anaphylactic reaction
  • glaucoma
  • muscle weakness
  • frequent urination
  • urinary disorder
  • urgency
  • neurogenic bladder
  • skin tingling
  • generalized edema
  • male perineal pain
  • insomnia
  • anxiety
  • decreased libido
  • back pain
  • vaginal bleeding
  • myocardial infarction
  • decreased cardiac output
  • syncope
  • hearing impairment
  • soft tissue infection
  • headache
  • thirst
  • drowsiness

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a closed container to protect it from air and moisture. It is advisable to maintain storage temperatures between 1 to 30 degrees Celsius at room temperature. Proper storage conditions will help preserve the medication's efficacy and safety over time.

Appearance and packaging

Appearance

Bright pink round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.